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Activity Number: 197 - Health Data Analytics
Type: Contributed
Date/Time: Tuesday, August 4, 2020 : 10:00 AM to 2:00 PM
Sponsor: Government Statistics Section
Abstract #309830
Title: Assessment of Relative Abuse Potential of Combined Gabapentinoid and Opioid Use
Author(s): Ling Chen*
Companies: CDER/FDA
Keywords: Abuse potential; Gabapentinoid; Relative difference; Prescription opioids
Abstract:

The Gabapentinoid drugs, gabapentin and pregabalin, were originally developed as antiseizure drugs with some limited indications for treatment of pain. Now, despite these limited indications, gabapentin and pregabalin are widely prescribed off-label for various other pain syndromes. The number of patients who filled a gabapentin or pregabalin prescription has increased annually since 2012. Data collected in 2016 from an office-based physician survey showed that 14 and 19 percent of patient encounters involving gabapentin and pregabalin, respectively, also involved opioids. Reports of Gabapentinoid abuse alone, and of Gabapentin abuse with opioids, have emerged. There are serious consequences of this co-use, including respiratory depression and increased risk of opioid overdose death. A question has been raised as to how to assess the abuse potential of a combination of Gabapentinoid and opioid. This presentation will discuss the choice of difference or relative difference between the combination and opioid alone in the assessment of abuse potential for the combination, and the sample size calculation for the comparison.


Authors who are presenting talks have a * after their name.

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